Advertisement

May 1, 2016

B. Braun Will Distribute NuMed's Newly Approved Cheatham Platinum Stent to Treat Coarctation of the Aorta

May 2, 2016—B. Braun Interventional Systems Inc. announced that it will be the exclusive distributor in the United States for the Cheatham Platinum (CP) stent (NuMed Inc.), which is designed to help treat patients with native and/or recurrent coarctation of the aorta. The CP stent is offered in bare, covered, and mounted configurations.

On March 25, NuMed Inc. received US Food and Drug Administration clearance for the CP stent. The device will be commercially launched in the United States during the Society for Cardiovascular Angiography and Interventions 2016 scientific sessions on May 4–6 in Orlando, Florida.

The CP stent is supported by the prospective, multicenter Coarctation of the Aorta Stent Trials: COAST and COAST II. The trials were sponsored by Richard Ringel, MD, who is Associate Professor of Pediatric Cardiology at Johns Hopkins University in Baltimore, Maryland. Dr. Ringel is the Director of the Pediatric Cardiac Catheterization Laboratory and Co-Director of the Adult Congenital Heart Disease Program at Johns Hopkins.

In April 2015, the 2-year outcomes from COAST were published by Jeffery Meadows, MD, et al online ahead of print in Circulation. COAST was designed to assess the safety and efficacy of the CP stent when used in children and adults with native or recurrent coarctation. The COAST investigators concluded that it is safe and associated with persistent relief of aortic obstruction.

Advertisement


May 2, 2016

Modifications Strengthen SALUS Pivotal Trial of Direct Flow Medical's TAVR System

May 2, 2016

Modifications Strengthen SALUS Pivotal Trial of Direct Flow Medical's TAVR System


)